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iwfal

10/28/12 12:11 PM

#151373 RE: pollyvonwog #151371

If MNTA can't get en banc or the supreme court to turn it around, I would also have to imagine MNTA/FDA would approach things differently in the future.



I would suggest it will be hard to change their approach for a variety of reasons:

A) they have already put a lot of the data in patents - especially for Copaxone, but even for biologics.

B) the FDA is probably not going to be particularly effective at halting the flow of proprietary information. Especially if it is counter to their perceived mission of getting as many generics on market as possible. (I have seen this play out several times as different agencies - personnel in govt agencies are generally dismissive of the protected nature of proprietary data. "oh, that's obvious so I am not going to protect it.")